This Warning Letter is notification from the United States Food and Drug Administration (FDA) advising you that Wal-Mart was observed to be in violation of federal tobacco laws and regulations. Failure to correct these violations may lead to federal enforcement actions, including monetary penalties. Your response is requested in 15 working days.

On January 2, 2018, an inspector representing the FDA completed an inspection of the establishment, located at 2021 Independence Street, Cape Girardeau, MO 63701. During this inspection the establishment was in violation because you or your employee sold cigarettes to a minor.

This inspection revealed that the establishment sells, distributes, and/or advertises tobacco products, including cigarettes, which requires that the establishment and its owners comply with federal laws and regulations governing such practices. The violation observed during the January 2, 2018, inspection includes the following:

1.A minor was able to buy Camel Blue 99’s cigarettes on January 2, 2018, at approximately 10:48 AM in the establishment.

A retailer must NOT sell cigarettes, cigarette tobacco, roll-your-own tobacco, and/or smokeless tobacco to a person younger than 18 years of age. Doing so violates 21 C.F.R. § 1140.14(a)(1) (2016).

The listed violation causes your cigarettes to be “misbranded” under 903 of the FD&C Act (21 U.S.C. § 387c).

You should immediately correct the violation listed above. Failure to correct the violation may result in FDA taking regulatory action without further notice. These actions may include, but are not limited to, civil money penalty, no-tobacco-sale order, seizure, and/or injunction.

The violation indicated in this letter may not be a complete list of violations at the establishment.

Please be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the Act. These products include, but are not limited to, electronic nicotine delivery systems (including e-cigarettes), e-liquids, cigars, and pipe tobacco. See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016), available at https://federalregister.gov/a/2016-10685.

For more information on these requirements, helpful resources for retailers, a database of inspections, and retailer education materials, visit our website at http://www.fda.gov/TobaccoProducts. The following Guidance documents provide additional information on compliance with retailer responsibilities:

You have 15 working days from the date you receive this letter to respond. In your response, explain your plan for correcting the listed violation and preventing future violations. Include a telephone number and address. Note your reference number of 18MO032836 in your response and mail it to:

Food and Drug Administration

Center for Tobacco Products

Document Control Center

Building 71, Room G335

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

If you have any questions, contact the Center for Tobacco Products via email at CTP-WL@fda.hhs.gov or via phone at 1-877-CTP-1373, option 6. Have your reference number ready when you call and include it with any email communications.